On January 25, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has received its first payment of approximately $2,200,000 from Gebro Holding GmBH (Press release, Can-Fite BioPharma, JAN 25, 2018, View Source [SID1234523563]). Can-Fite recently announced entering into a distribution agreement with Gebro for the exclusive right to distribute to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of rheumatoid arthritis and psoriasis in 3 European countries including Spain, Switzerland and Austria, upon receipt of regulatory approvals. The recently signed Gebro distribution agreement adds to the distribution agreements for Piclidenoson that the company already has in place with Cipher Pharmaceuticals (for the distribution of Piclidenoson in Canada for rheumatoid arthritis and psoriasis) and Kwang Dong Pharmaceutical (for the distribution of Piclidenoson in Korea for rheumatoid arthritis).

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Under the terms of the distribution agreement, Gebro is making a total upfront and milestone payment of approximately $2,200,000 to Can-Fite. In addition, the agreement provides that additional payments of up to approximately $7,000,000 will be received by Can-Fite upon the achievement of certain regulatory, launch and sales milestones plus double digit royalty payments on net sales.

Gebro Pharma is a privately-owned leading pharma group founded in Austria in the late 1940s with over 500 employees. Its headquarters are located in Fieberbrunn (Austria), where Gebro is a top local leading player, with commercial operations in Spain and Switzerland. In Spain, Gebro is ranked among the top growing companies within the Pharma sector. The therapeutic focus of Gebro is pain with a strong franchise in rheumatology and in Spain, Gebro is ranked nº1 in rheumatology and pain. Alongside, rheumatology and pain, Gebro has also built a portfolio around dermatology, urology, respiratory, GI, and CV depending on the territory.

"We are pleased to receive this upfront and milestone payment of $2,200,000 from Gebro and look towards future potential milestone payments as we advance Piclidenoson through completion of our current Phase III trials in rheumatoid arthritis and psoriasis," stated Can-Fite CEO Dr. Pnina Fishman. Can-Fite recently initiated patient enrolment for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis.

The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

On January 24, 2018 Sorrento Therapeutics, Inc. (NASDAQ:SRNE) ("Sorrento"), reported the expansion of its Good Manufacturing Practices (GMP) CAR-T manufacturing capacity, with an exclusive agreement to operate the "Cellular Immunotherapy and Gene Therapy Facility" at Roger Williams Medical Center (Providence, RI) under Sorrento management (Press release, Sorrento Therapeutics, DEC 24, 2018, View Source [SID1234532248]).

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Sorrento estimates that the combination of its East and West Coast manufacturing capacity will allow the company to process CAR-T treatments for over 300 patients a year without the use of a third-party contract manufacturer. Sorrento believes that the current capacity should be sufficient to meet its lead candidate CD38 CAR-T multiple myeloma development needs through and up to FDA approval, and support other upcoming CAR-T development programs.

This latest facility addition brings the total GMP manufacturing sites of Sorrento and its subsidiaries to 5 separate facilities: Judicial Facilities (San Diego, CA) for CAR-T therapies and antibody production, Providence Facilities (RI) for CAR-T therapies, Camino Santa Fe Facilities (San Diego, CA) for oncolytic virus production, Suzhou Facilities (China) for antibody-drug conjugate (linker toxin synthesis and bio conjugation) production and Bioserv Corporation (San Diego, CA) for small molecule and biologics fill and finish, medical devices and high potency compound fill and finish (expected completion later in the year).

"We decided a long time ago that internal manufacturing capability would be a strategic asset for Sorrento," stated Henry Ji, Chairman and CEO. He also noted, "Many biotech companies learned the hard way the risks of entering into a new therapeutic area without internal manufacturing capabilities and having to compete with other companies for limited numbers of third party manufacturers. With all the recent activity in the CAR-T space we are extremely pleased to be in control of our own GMP manufacturing and not have to rely on outside parties for our supply needs for our current and future development work."

As Sorrento moves towards non-viral CAR manufacturing, it also expects both the Judicial and Providence Facilities to be able to increase their capacity throughput and handle multiple CAR-T development programs in parallel.

(Filing, Annual, Novartis, 2017, JAN 24, 2018, View Source [SID1234523540])

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On January 24, 2018 SELLAS Life Sciences Group, Inc. (SELLAS; NASDAQ: SLS) reported that an abstract highlighting the detailed description of antigen-specific immune responses and correlation thereof with clinical effects over time has been accepted for oral presentation at the 2018 European Society for Blood and Marrow Transplantation (EBMT) 44th Annual Meeting taking place March 18-21 in Lisbon, Portugal (Press release, Sellas Life Sciences, JAN 24, 2018, View Source [SID1234523569]).

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"The abstract to be presented at the EBMT Conference highlights the depth of our clinical program exploring the potential of GPS as an innovative immunotherapeutic for multiple cancer types," said Angelos M. Stergiou, MD, ScD h.c., President and CEO of SELLAS. "There has been great interest in immuno-oncology approaches for the treatment of MM and GPS offers an exciting opportunity by directly immunizing the host against a key immune target in multiple myeloma, namely WT1, particularly in view of strong differentiating attributes of our hetereoclitic immunotherapeutic as well as the other indications we are carefully pursuing."

Multiple myeloma (MM) patients with high-risk cytogenetics at baseline who also remain positive for minimal residual disease post-frontline autologous stem cell transplantation continue to experience poor clinical outcomes, despite maintenance with immunomodulatory drugs, such as lenalidomide. This is a population segment that represents approximately 15-20% of first-line MM patients. In previous reports, such patients immunized with GPS in a Phase 2 study (n=18) experienced a median progression-free survival of 23.6 months and an 18 month overall survival of 88%.

The presentation at the EBMT Conference will entail detailed correlative analyses between clinical benefit, as reflected by the rate of achievement of complete response/very good partial response, per International Myeloma Working Group criteria, and antigen-specific immuno-responses of the complete dataset from this Phase 2 study.

Details for the presentation are as follows:

Title: Clinical Benefit after Galinpepimut-S (GPS), a WT1 Immunotherapeutic, Correlates With Antigen-Specific Immune Responses in High-Risk Multiple Myeloma: Complete Analysis of the Phase 2 GPS Maintenance Study.
Presenter: Guenther Koehne, MD, PhD, Miami Cancer Institute, Baptist Health South Florida
Session: Oral Session 4 – Multiple Myeloma; Room 5B
Abstract Number: A-947-0029-01047
Date/Time: March 19, 2018, 3:50 p.m WET/ 10:50 a.m. EST
Location: Centro de Congressos de Lisboa / Lisbon Congress Centre (LCC), Room 5B
The presentation will be made available on the Presentations section of Sellas’ website at www.sellaslifesciences.com/publications immediately following the presentation.

About galinpepimut-S (GPS)

GPS is a heteroclitic multivalent, multi-peptide cancer immunotherapeutic agent composed of four peptides, addressing over 20 epitopes, and derived from the WT1 protein, which has been ranked by the National Cancer Institute as a top priority among cancer antigens for immunotherapy. Importantly, because the WT1 antigen is over-expressed in many malignancies, and is not found in most normal tissues, GPS has the potential to be a broad immunotherapy, effective across a multitude of diverse cancer types and patient populations.

On January 24, 2018 Pfizer Inc. reported that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan (rituximab-US)/MabThera1 (Press release, Pfizer, JAN 24, 2018, View Source [SID1234523567]).

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The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.

"We are pleased to report on our fifth proposed biosimilar monoclonal antibody (mAb) with positive study results. These results reinforce the potential of our proposed rituximab biosimilar in providing a safe and effective treatment option for patients," said Amrit Ray, MD, global president, Pfizer Essential Health Research and Development. "As a global leader in novel biologics, and with one of the broadest global portfolios in oncology, we are delivering on our commitment to advancing high-quality medicines for the millions of patients with cancer around the world today and in the future."

Pfizer’s biosimilars pipeline consists of seven distinct biosimilar molecules in mid to late stage development, with three of these in oncology, as well as several others in early stage development.

About the REFLECTIONS B3281006 Study

REFLECTIONS B3281006 is a randomized, double-blind clinical trial evaluating the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus MabThera (rituximab-EU)for the first-line treatment of patients with cd20-positive, low tumor burden, follicular lymphoma. The primary endpoint measure, ORR, is defined according to the revised response criteria for malignant lymphoma [Time Frame: Week 26]. Results of the study will be presented in full at a future medical meeting or summarized in publication.

More information about the PF-05280586 REFLECTIONS B3281006 study can be found at www.clinicaltrials.gov.

About PF-05280586

PF-05280586 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Rituxan/MabThera. Rituxan/MabThera is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin’s lymphoma; CD20-positive chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with Polyangiitis and Microscopic Polyangiitis; and other region-specific indications.

PF-05280586 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities.